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January 11, 2019 -- The U.S. Food and Drug Administration (FDA) has released a draft regulatory framework and other new documents that delineate the agency's vision and plans for its Software Precertification (Pre-Cert) initiative for developers of medical software, including artificial intelligence (AI) applications.

The de novo pathway is well-suited for the Pre-Cert program, as it is a marketing authorization pathway for certain novel types of low- to moderate-risk devices, said FDA Commissioner Dr. Scott Gottlieb in a statement. He noted that companies currently submitting products for review under the de novo pathway must meet applicable Quality System Regulation (QSR) requirements to demonstrate that they make products that are safe and effective and meet the de novo statutory standard.

Under the proposed Pre-Cert regulatory framework, many of these QSR requirements would be satisfied by information collected during a proposed Excellence Appraisal process, which is designed to evaluate the quality and excellence of the software developer for the Pre-Cert program, he said.

The FDA has also published its Pre-Cert 2019 Test Plan, which details the agency's plan for testing this streamlined de novo pathway.

"To do so, we will review the sponsor's traditional de novo submission for its device and using that same submission information we will, in parallel, review the sponsor's Excellence Appraisal information with the proposed streamlined submission content," Gottlieb said. "The sponsor will incur no additional burden. Instead, the FDA will set up two parallel review processes, one using the Pre-Cert model and one using the traditional approach to the review of a de novo application."

This approach will help the FDA show that the proposed Excellence Appraisal and streamlined premarket review submission will provide the same quality and type of information as the traditional de novo review process for determining whether a software developer's products meet the FDA's statutory safety and effectiveness standard, he noted.

The FDA has also released a third draft of its Working Model, which now incorporates the new regulatory framework and test plan. It describes the proposed implementation approach and also outlines the agency's broader vision for the Pre-Cert program, according to Gottlieb.